IRISYS Awarded NIH “Drug Formulation and Manufacturing” Contract for Up To $45 Million
SAN DIEGO, Nov. 5, 2019 /PRNewswire/ -- IRISYS, LLC, a San Diego-based provider of contract pharmaceutical product development and manufacturing services today announced that it has been awarded a new “Drug Formulation and Manufacturing” contract by the Office of Logistics and Office of Administration at the National Institutes of Health (NIH).
The contract ordering period runs through September 26, 2024. The reimbursement to IRISYS will be up to a maximum of $45 million. The actual amount awarded will depend on the number and value of individual Task Orders and whether IRISYS is selected, among other awardees, to complete each Task Order.
The goal of the contract is to complete all the manufacturing, documentation, formulation, fill and finish, packaging and labeling required for both sterile and non-sterile investigational drug products for human clinical trials. Throughout the period of performance, IRISYS must maintain the technical capabilities, minimum resources and organizational compliances to successfully conduct any awarded contract activity.
“IRISYS is honored to be selected by NIH to receive this, the largest of the four prime contracts awarded by the NIH since 2010,” said Robert Giannini, Ph.D., President, CSO/CTO. “The IRISYS team is proud to support the NIH mission.”
This project has been funded in whole or in part with Federal funds from the Office of Logistics and Office of Administration, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N98019D00058. The content of this press release is solely the responsibility of IRISYS and does not necessarily represent the official views of the National Institutes of Health.
In addition to working with government agencies, IRISYS has a wide range of clients, partners and collaborators that include both U.S. and international companies, from start-up organizations to mid-tier biopharma companies. IRISYS also offers strategic regulatory consulting related to the drug development process, including customized services for international clients.
About IRISYS, LLC ( www.irisys.com )
IRISYS was founded in 1996 by chairman and CEO Gerald Yakatan, Ph.D. to provide contract pharmaceutical product development and manufacturing services, specializing in formulation development, cGMP manufacturing of clinical trial materials and commercial pharmaceutical products, and strategic consulting related to the drug development process.
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